Kinematic Versus Mechanical Alignment in Total Knee Replacement: a Randomized Double-blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.
详细描述
Total knee arthroplasty (TKA) is known, to significantly improve function and satisfaction in arthritic knee patients; nevertheless, a substantial percentage of these patients are not fully satisfied. Thus, several authors reported significantly improved outcomes after slightly under correcting varus knees after TKA. The concept of kinematic alignment (KA) even more addresses the patient´s individual anatomy with three-dimensional restoration of individual axes, joint lines and joint envelope of laxity. The aim of this prospective randomized study was to demonstrate equivalence between mechanical and kinematic alignment in restoring knee function in terms of subjective and objective outcomes.
In this prospective randomized controlled double-blind study 120 patients with osteoarthritic knees will be treated with a Medial Pivot TKA (Medacta Sphere GMK). The patients are divided into two groups. Group A receive the TKA using mechanical alignment principles, group B receive the kinematic alignment. The surgical technique was equal in both groups. CT-based 3D printed PSI cutting blocks were used for the saw cuts. Pre and postoperative standard x-rays were performed. To determine the subjective and objective outcomes the OKS(Oxford Knee Score), the KSS(Knee Society Sore), the FJS-12(Forgotten Joint Score) and the WOMAC Score were collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis of the knee
- •Primary TKA
- •UCLA Score (University of California, Los Angeles Score)>/= 4
- •mMPTA: 85°- 90°
- •Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral
排除标准
- •Minor Patient
- •Pregnant or breast feeding woman
- •Difference in the radius of medial and lateral condyles >2mm
- •Previous osteotomy around the knee
- •Ligament instability likely to require higher level of constraint
- •Previous infection or inflammatory disease
- •Any Patient who cannot or will not provide informed consent for participation in the study
结局指标
主要结局
Knee Society Score (KSS)
时间窗: 24 months postoperative
The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
次要结局
- Forgotten Joint Score (FJS-12)(24 months postoperative)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(24 months postoperative)
- Oxford Knee Score (OKS)(24 months postoperative)